The following data is part of a premarket notification filed by Unipack Medical Corporation with the FDA for Unipack Barrier Sleeve And Barrier Film And Uniglide Barrier Envelope.
| Device ID | K183263 |
| 510k Number | K183263 |
| Device Name: | UNiPACK Barrier Sleeve And Barrier Film And UNiGLIDE Barrier Envelope |
| Classification | Dental Barriers And Sleeves |
| Applicant | UNiPACK Medical Corporation 9830 Norwalk Blvd., Suite 100 Santa Fe Springs, CA 90670 |
| Contact | Joe Pomparelli |
| Correspondent | Joe Pomparelli UNiPACK Medical Corporation 9830 Norwalk Blvd., Suite 100 Santa Fe Springs, CA 90670 |
| Product Code | PEM |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-23 |
| Decision Date | 2019-06-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D784UBC80495 | K183263 | 000 |
| D784UBC80485 | K183263 | 000 |
| D784UBC80475 | K183263 | 000 |
| D784UBC80465 | K183263 | 000 |
| 40665973029373 | K183263 | 000 |
| 00665973027227 | K183263 | 000 |
| 00665973027210 | K183263 | 000 |
| 20371347011955 | K183263 | 000 |
| 20371347011948 | K183263 | 000 |